Devices and methods for inserting a vertebral fixation member

ABSTRACT

Devices, systems, and methods for inserting a vertebral stabilization member, such as a rod. The insertion device includes an outer guide tube, a pin assembly including a pin and a pusher member extending therethrough. The insertion device is configured to actuate a rod between a first orientation and a second orientation angled with respect to the first orientation in order to position the rod in an appropriate location for attachment to bone.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation application of U.S. patentapplication Ser. No. 12/413,058 filed on Mar. 27, 2009, the entiredisclosure of which is incorporated herein by reference in its entiretyfor all purposes.

FIELD OF THE INVENTION

The present invention relates generally to devices and methods forinserting a vertebral fixation member, and more particularly, but notexclusively, to rod insertion devices and methods.

BACKGROUND OF THE INVENTION

Many types of spinal irregularities can cause pain, limit range ofmotion, or injure the nervous system within the spinal column. Theseirregularities can result from, without limitation, trauma, tumor, discdegeneration, and disease. Often, these irregularities are treated byimmobilizing a portion of the spine. This treatment typically involvesaffixing a plurality of screws and/or hooks to one or more vertebrae andconnecting the screws or hooks to an elongate rod that generally extendsin the direction of the axis of the spine.

Treatment for these spinal irregularities often involves using a systemof pedicle screws and rods to attain stability between spinal segments.Instability in the spine can create stress and strain on neurologicalelements, such as the spinal cord and nerve roots. In order to correctthis, implants of certain stiffness can be implanted to restore thecorrect alignment and portion of the vertebral bodies. In many cases, ananchoring member such as a pedicle screw along with a vertical solidmember can help restore spinal elements to a pain free situation, or atleast may help reduce pain or prevent further injury to the spine.

As the science and technology of spine surgery continues to progress,there is an increasing interest in developing alternative, minimallyinvasive, methods to conventional “open” spine surgery. The goals ofthese less invasive alternatives are to avoid the surgical exposure,dissection, and retraction of muscles and tissues that is necessary with“open” surgery. In general, a minimally invasive spine surgery systemshould be able to perform the same procedure as the traditional opentechnique, but through smaller incisions instead of one longer incision.As a result, some physicians feel that using a minimally invasive spinesurgery system generally causes less soft tissue damage, reduces bloodloss and reduces recovery time. In addition, patients generally preferthe smaller scars that are left using a minimally invasive approach.

Historically, spine fusion surgery including pedicle screw fixation withdeep placement of rods has been one area that has presented significantchallenges for minimally invasive approaches. However, advancement intechnologies such as fluoroscopy and improvements in optics havecontributed to the advent of a few minimally invasive spine fusionsurgery techniques.

SUMMARY OF THE INVENTION

A device and method for inserting a vertebral stabilization member isdisclosed. In one embodiment, the stabilization member is realeasablyclampable to an insertion device between first and second clampingmembers at a clamping location spaced from a midline of thestabilization member. The insertion device and stabilization member aredeliverable through an access sleeve and the stabilization member isrotatably actuatable to position the stabilization member in relation toa bone anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more readily understood with reference to theembodiments thereof illustrated in the attached drawing figures, inwhich:

FIG. 1 is a perspective view of one embodiment of a stabilization memberand insertion device shown during on embodiment of an installationmethod according to the present invention;

FIG. 2 is a perspective view of one embodiment of a stabilization memberinsertion device according to the present invention;

FIG. 3 is an exploded view of one embodiment of a screw;

FIG. 4 is an exploded view of another embodiment of a screw;

FIG. 5 is an assembly view of the embodiment of the screw of FIG. 4;

FIGS. 6-7 are side and front views of one embodiment of an accesssleeve;

FIG. 8 is an exploded view of one embodiment of the insertion device ofFIG. 2;

FIG. 9 is a perspective view of one embodiment of a stabilization memberaccording to the present invention;

FIGS. 10-11 are enlarged side and top views of the stabilization memberof FIG. 9;

FIGS. 12-13 are perspective views of left and right clamp members,respectively;

FIG. 14 is a perspective view of a longitudinal pin assembly;

FIG. 15 is an enlarged partial perspective view of the insertion deviceof FIG. 2 shown in a first position;

FIG. 16 is an enlarged partial perspective view of the insertion deviceof FIG. 2 shown in a second position;

FIG. 17-18 are side and rear partial perspective views of the insertiondevice of FIG. 2 shown in the second position;

FIG. 19 is a partial cross-sectional view of the insertion device ofFIG. 2, shown with the clamp assembly unclamped to the stabilizationmember;

FIG. 20 is a partial cross-sectional view of the insertion device ofFIG. 2, shown with the clamp assembly clamped to the stabilizationmember;

FIG. 21 is a partial cross-sectional view of the insertion device ofFIG. 2 shown in a first position;

FIGS. 22-24 are partial cross-sectional views of the insertion device ofFIG. 2 shown in second, third and fourth positions, respectively;

FIG. 25 is a perspective view of another embodiment of a stabilizationmember and insertion device shown during another embodiment of aninstallation method according to the present invention;

Throughout the drawing figures, it should be understood that likenumerals refer to like features and structures.

DETAILED DESCRIPTION

The various embodiments of the invention will now be described withreference to the attached drawing figures. The following detaileddescription of the invention is not intended to be illustrative of allembodiments. In describing the various embodiments of the presentinvention, specific terminology is employed for the sake of clarity.However, the invention is not intended to be limited to the specificterminology so selected. It is to be understood that each specificelement includes all technical equivalents that operate in a similarmanner to accomplish a similar purpose. The features of one embodimentmay be employed with other embodiments as the skilled artisan wouldrecognize, even if not explicitly stated herein.

Referring to FIG. 1, one embodiment of a stabilization member insertiondevice 10 is shown positioned within one embodiment of a sleeve 22 thatis mated to a first anchor 12. A second anchor 14 is shown attached to asecond sleeve 24. A connecting member or stabilization member 16 isshown attached to device 10 and is configured to connect and/or extendbetween the first and second anchors 12, 14 for stabilizing at least aportion of a vertebrae of a patient. According to one variation, firstanchor 12 may be positioned within a body of a patient through any knownsurgical methods, including but not limited to, through a firstminimally invasive or percutaneous opening. Second anchor 14 is alsopositionable within a body of a patient through any known surgicalmethods, including but not limited to, through a second minimallyinvasive or percutaneous opening. In the alternative, first and secondanchors 12, 14 may be inserted through an open, mini-open, or mixed openand minimally invasive procedure. In one embodiment, first and secondanchors 12, 14 are configured to engage first and second vertebra.

Stabilization member 16 is positionable within the body of a patientthrough a first opening in the skin to engage and connect first andsecond anchors 12, 14. According to one embodiment, one of sleeves 22,24 may extend from anchors 12, 14 and facilitate insertion of anchors12, 14 into a vertebral body. Stabilization member 16 may be installedbetween anchors 12, 14 and clamping members, screw caps or set screwsmay be installed for fixation of stabilization member 16 to anchors 12,14. Stabilization member 16 may be installed through any known surgicalmethods including, but not limited to minimally invasively,percutaneously or through an open procedure or non-percutaneously intoreceiving portions or channels 26 of anchors 12, 14. According to oneembodiment, connecting member or stabilization member 16 generallycomprises an elongate rod or shaft. Stabilization member 16 may have anarcuate or curvilinear shape. In alternative embodiments, however,stabilization member 16 can include any configuration known for a rod,implant, or fastener, and can be straight or have any curvature alongits length including a compound curvature. As shown in FIG. 1, astabilization member insertion device 10 may be inserted into sleeve 22to facilitate insertion of stabilization member 16 into anchors 12, 14.Although a second sleeve 24 is depicted in FIG. 1 as being attached toanchor 14, a second sleeve 24 may or may not be connected to secondanchor 14, depending on the preference of a surgeon user.

In one embodiment, stabilization member insertion device 10 isreleasably and rotatably linked to the stabilization member 16 and thestabilization member insertion device 10 is configured and dimensionedto be received within a single sleeve 22, 24 such that the insertiondevice 10 and stabilization member 16 are moveable in the longitudinaldirection within the sleeve to position stabilization member 16 adjacentthe distal end thereof. As will be discussed in more detail below,stabilization member 16 is deliverable through the sleeve in a firstorientation substantially parallel to the axis of the sleeve and isrotatable to a second orientation at an angle with respect to the firstorientation. Furthermore, the stabilization member 16 is rotatablyactuatable by insertion device 10 independent of movement along the axisof the sleeve, i.e. the stabilization member 16 may be rotated byinsertion device 10 anywhere along the length of the sleeve. Such afeature may be particularly advantageous, for example, to adjust thepathway or route that the stabilization member 16 travels through thebody tissue during installation. In this regard, those skilled in theart will appreciate that a virtually limitless number of differentpathways that a stabilization member 16 may travel and this featuresprovides great flexibility to a surgeon user. In addition, due to theindependent aspect of the rotation of the stabilization member, rotationmay be actuated or independently controlled without moving the insertiondevice with respect to sleeve 22. In this regard, rotation ofstabilization member 16 may be rotated without downward exertion offorce upon the sleeve and/or anchor.

Referring now to FIGS. 3-5, exemplary embodiments of anchors that may beutilized with the invention are shown. Referring to FIG. 3, oneembodiment of an anchor 32 is shown and generally comprises a bonefastener such as a bone screw 32 with a head 34 and a shaft or shank 36having bone engaging threads. As shown in FIG. 3, screw 32 is cannulatedwith a central passage or lumen 38 extending along a central axis 39,however, non-cannulated screws may also be used. Head 34 includes a toolengagement surface or opening 40 configured to receive a driving tool toprovide torque and drive the screw into bone. In one embodiment, screw32 is a polyaxial screw assembly that has a coupling element 42pivotably coupled to, head 34 of screw 32. A wedge 43 and clamp assembly45 may be housed within coupling element 42 to facilitate locking thescrew 32 with respect to coupling element 42. In this regard, screw 32is capable of rotating within coupling element 42 to selectably assume aplurality of angles. Referring to FIGS. 4-5, another exemplaryembodiment of a bone screw 32 is shown. Still another example of apolyaxial screw that may be used with the present invention is describedin U.S. Pat. No. 7,503,924, the entire contents of which areincorporated by reference.

Referring to the embodiments of FIGS. 3-5, coupling element 42 isconfigured and adapted to receive the stabilization member 16. Ingeneral, coupling element 42 includes a U-shaped body 44 defining achannel 26 in which stabilization member 16 may be locked or fixed inplace by, for example, a locking cap. In alternate embodiments,alternative means of rigidly coupling stabilization member 16 to ananchor may be used by those skilled in the art, including alternativeconfigurations of coupling elements and locking devices or methods. Inone embodiment, coupling element 42 includes features to couple withsleeves 22, 24.

In the illustrated embodiment, a sleeve may extend from the anchors 12,14 and provide a portal or passageway through the body of a patient toaccess anchors 12, 14. Referring to FIGS. 6-7, one embodiment of asleeve 50 according to the invention is shown comprising cannula 54extending from a proximal end 56 to a distal end 58 along an axis 60. Acentral channel 62 extends axially through sleeve 50. In this regard,cannula 54 generally comprises an extended tube with a generallycylindrical top portion 64 and a pair of generally rigid arms 66, 68extending axially from top portion 64 in a distal direction. Slots oropenings 76 extend along the lateral sides of sleeve 50 to provideaccess to central channel 62 of sleeve 50. Sleeve 50 may be made of anymaterial suitable for surgical instruments. In one preferred embodiment,sleeve 50 may be made of a metallic material.

In operation, arms 66, 68 of sleeve 50 may include a retainer portion 82at its distal end to attach an anchor to the distal end of sleeve 50. Inthis regard, arms 66, 68 may include projections 84 extending laterallyinward from the distal end to engage a corresponding feature on theanchor to provide additional retention capability.

When sleeve 50 is assembled to an anchor, as shown in FIG. 1, couplingelement 42 of bone screw 32 is received within retainer portion 82 at adistal end 58 of sleeve 50. In this regard, retainer portion 82 maysnappably or resiliently receive the coupling element 42 of screw 32.The inner wall 85 of retainer portion 82 is shaped to conform to theouter perimeter of coupling element 42 such that when arms 66, 68 engagean anchor, the coupling element 42 of screw 32 is rotationally andaxially fixed with respect to sleeve 50 or radially contained withinsleeve 50

Referring now to FIGS. 8-11, one embodiment of a stabilization member 16and insertion device 10 is shown. As shown in FIGS. 9-11, stabilizationmember 16 generally comprises an elongate rod 100 extending from aproximal end 102 to a distal end 104 along an axis 106. In oneembodiment, rod 100 is curved or arcuate along its length. However, inalternate embodiments, rod 100 may have any alternate shape. Accordingto one aspect of the embodiment, rod 100 includes a generally tapered orconical shaped nose or tip 108 at its distal end 104 to facilitateinsertion and installation of rod 100 into the body of a patient. Inalternate embodiments, tip 108 may have varied shapes and sizes.Proximal end 102 of rod 100 comprises a generally concave or roundedramped tip surface 109 angled with respect to longitudinal axis 106configured and dimensioned to interface or engage with actuating orpushing member 116 of insertion device 10.

Referring to FIG. 8, insertion device 10 generally comprises a means forclamping to or holding stabilization member 16 and means forcontrollably actuating or rotating the stabilization member 16 about thedistal end of the device. According to one variation, insertion device10 is an assembly generally comprising a pair of clamp members 110, 112pivotably attached adjacent a distal end 114 that may be selectablyactuatable to clamp, fix or hold the stabilization member 16 adjacentthe distal end thereof. Insertion device 10 additionally comprises adrive shaft or actuatable pusher assembly 116 extendable centrallywithin an outer guide tube 118 and linearly advanceable with respectthereto to facilitate the rotation or pivoting of the stabilizationmember 16 with respect to guide tube 118.

Referring again to FIGS. 9-11, in one embodiment, rod 100 may include apair of diametrically opposed indentations 124 spaced from proximal end102 of rod 100. In one variation, indentations 124 are generallyelongate grooves extending generally parallel with axis 106.Indentations 124 are configured and dimensioned to releasably rotatablyengage clamp members 110, 112 of insertion device 10 such that rod 100may pivot with respect to distal end 114. To attach rod 100 to clampmembers 110, 112, clamp members may be separatable to engage or snapinto indentations 124. In operation, once ridges cooperatively engageindentations 124, rod 100 may rotate or pivot about distal end 114.

One embodiment of a means for clamping comprises a left clamp member 110and a right clamp member 112 pivotably attached to a distal end of guidetube 118. A pair of openings 146 are provided adjacent the distal end ofguide tube 118 and receives clamp members 110, 112 therein to releasablyclamp to rod 100 such that rod 100 may rotate thereabout.

Referring to FIGS. 12 and 13, finger or flange portions 132 extendlaterally inward from clamp member sidewalls 134 and define a hole 136extending longitudinally therethrough. Clamp members 110, 112 may beassembled with flange portions 132 overlapping laterally and with holes136 aligned to receive a pin 138 and defining a pivot axis 140. In thisregard, the left and right clamp members 110, 112 may pivot with respectto each other about pin 138 and axis 140. A clamp ridge 142 may bedefined along a portion of the lower edge of each clamp member 110, 112such that when clamp members 110, 112 pivot about axis 142, ridges 142may move towards and away from each other to hold, clamp, or fix rod 100therebetween. According to one variation, rod 100 may be clamped or heldabout the upper portion thereof and with clamp members 110, 112 withinthe profile of rod 100 such that no portion of clamp members 110, 112extend or protrude beyond the radius of rod 100. In one embodiment, rod100 is generally cylindrical with a generally circular cross section andclamp members 110, 112 engage rod 100 on an upper portion of the rodspaced from the midline or diameter of the rod. In this regard, whenclamp members 110, 112 are in a clamping position to clamp or hold rod100, they are generally spaced apart a distance less than the diameterof the rod. It may be appreciated that as a result of such a design, rod100 may be loaded directly into an anchor receiver member at the rodclamping location without requiring additional space or room to allowthe clamp members to enter therein. Those skilled in the art mayappreciate that such a feature may be advantageous in facilitating theuse of legacy anchors or screws without the requirement that receiverportions be especially sized and dimensioned and/or retrofitted toaccommodate clamp members 110, 112.

Clamp members 110, 112 may be pivoted about axis 140 or actuated toclamp rod 100 remote from the distal end 114 via pin assembly 150 thatextends through guide tube 118. Referring to FIG. 14, in one variation aproximal end 152 of the pin assembly has a block or finger portion 154.As shown in FIG. 8, finger portion 154 is configured to engage aninterior of thumb nut 156 such that as the thumb nut is rotated, the pinassembly 150 may be linearly advanced or retracted as desired by a user.Thumb nut 156 is internally threaded and threadably engages collar 172.In this regard, threaded collar 172 may be axially constrained to guidetube 118 via C-clip 170. In alternate embodiments, threaded collar 172may be integrally formed with guide tube 118 such as via welding.

As best seen in FIGS. 19-20, pin assembly 150 is axially moveable withinguide tube 118 and the distal end of pin 158 is configured to engageclamp members 110, 112 to cause the clamp members to pivot about axis140. In a first position, shown in FIG. 19, the distal most tip 160 ofpin 158 is spaced from the distal most end 114 of tube 118 and spaceddistally from between protrusions 144 of clamp members 110, 112. In thisposition, clamp members 110, 112 may pivot apart such that rod 100 isnot clamped therebetween. Referring to FIG. 20, pin assembly 150 may beadvanced to a second position, shown in FIG. 20, with the distal mosttip 160 of pin 158 advanced distally between protrusions 144. In thissecond or clamped position, the ridges 142 of clamp members 110, 112 maymove towards each other to clamp or hold rod 100 therebetween.

A protrusion 144 extends inward from each clamp member sidewall,respectively. Protrusions 144 are generally cylindrical with roundedfree ends configured and dimensioned to linkingly engage openingsprovided in the distal end of insertion device 10. Protrusions 144 aregenerally coaxially positionable within openings 146 and aligned along apivot axis 148 defined through the center thereof. Pivot axis 148extends generally perpendicular to a central axial plane of rod 100 andclamp pivot axis 140. In this regard, when assembled to device 10, clampmembers 110, 112 are axially fixed and rotatable about the distal endthereof such that when rod 100 is clamped therebetween, rod 100 maypivot about axis 148 during installation in a patient.

One embodiment of a means for controllably actuating, pivoting, orrotating the stabilization member 16 about the distal end of insertiondevice 10 generally comprises a first member and a second member,wherein the first member is linearly translatable with respect to thesecond member along the longitudinal axis of the device and thestabilization member is linkingly engaged to the first member androtatably engaged to the second member. When the first member istranslated with respect to the second member along the longitudinalaxis, the stabilization member rotates about the second member.According to one embodiment, shown in FIG. 8, stabilization memberinsertion device 10 generally comprises an outer guide tube 118 and apusher assembly 116 concentrically disposable within screw extension orsleeve 50 to position a stabilization member 16 in relation to theattached screw(s).

As best seen in FIG. 8, pusher assembly 116 generally comprises a pushermember 160 integral to a threaded drive shaft or stein portion 162.Pusher assembly 116 is configured and dimensioned to fit within outertube 118 such that it is moveable with respect to outer tube 118 along alongitudinal axis 164. A knob 166 is internally threaded to mate withexternal threads of drive shaft 162 Such that rotation of knob 166causes linear translation of pusher assembly 116 with respect to outerguide tube 118 along axis 164. Pusher member 116 includes a distal end168 configured and dimensioned to pushingly and/or slidingly engageproximal end 102 of rod 100.

In operation, when knob 166 is rotated, drive shaft 116 is moveddownward or in the distal direction along axis 164 and distal end 168 ofpusher member 116 pushes or drives the proximal end 102 of rod 100downward or in the distal direction and causes rod 100 to rotate orpivot about pivot axis 148. In this regard, referring to FIGS. 21-24,rod 100 is moveable from a generally upright orientation or position ora position wherein axis 106 is aligned with or parallel to axis 164(FIG. 21) to a more horizontal orientation or position or a positionwherein axis 144 is perpendicular or angled with respect to axis 106(FIG. 24). Thus, rod 100 may be advanced through sleeve 50 and installedin a patient utilizing a minimally invasive approach. As describedabove, in one embodiment stabilization member 16 is rotatably actuatableby insertion device 10 independent of movement along the axis of thesleeve, i.e., the stabilization member 16 may be rotated by insertiondevice 10 anywhere along the length of the sleeves 22, 24.

A handle 180 may be provided to facilitate insertion of device 10 intosleeves 22, 24. A longitudinal or axial stop may be provided along theexterior of insertion device 10 to ensure that the insertion device androd attached thereto extends a sufficient length into sleeves 22, 24,such that rod 100 may be positioned sufficiently proximate to anchors12, 14 attached to the distal ends of sleeves 22, 24.

Surgical techniques or methods using the above described system anddevice will now be described. According to one embodiment of the presentinvention, anchors 12, 14 may be implanted into the vertebraepercutaneously, minimally invasively, or through an open or mini-openprocedure. In one exemplary embodiment, at least one of the anchors 12,14 is attached to, mounted on, or retained in sleeve 50, and the sleeve50 and attached anchor are inserted through an open incision, a tube orcannula, or directly through the skin and tissue of the patient toimplant the anchor into bone, such as the pedicles of a vertebrae. Inalternate embodiments, anchors 12, 14 can be implanted into bone withouta sleeve 50 attached thereto, and sleeve 50 may be mounted on an anchorafter it is implanted. For example, as shown in FIG. 25, according toone embodiment, anchors 12, 14, may be installed utilizing a retractorsystem 190, and one of the anchors 12, 14 may have a sleeve attachedthereto while one or more additional anchors does not have a sleeveattached. One exemplary retractor system 190 that may be utilized isdisclosed in U.S. patent application Ser. No. 11/422,511, the entirecontents of which are incorporated herein by reference. In anotherexemplary embodiment, shown in FIG. 1, both anchors 12, 14 may have asleeve attached thereto.

Any imaging system known to those skilled in the art may be utilized todetermine and locate optimum placement and orientation of the anchors inthe vertebrae and/or to identify locations for entry of the anchors.Other methods known by skilled artisans for locating and placing anchors12, 14 into the vertebrae may be also used, including, but not limitedto, a CT scan or x-ray, any known viewing instrument or apparatus,endoscopic, and microscopic monitoring.

Any known methods of locating and preparing the pedicle for screwimplantation may be utilized. In this regard, according to one knownminimally invasive technique, after location of the entrance point,instrumentation of the pedicle may begin with the insertion of acannulated needle through the skin of a patient to the intersection ofthe facet and transverse process of a vertebral body to which an anchoris to be implanted. A Kirschner wire or guidewire may be insertedthrough the needle cannula and into the pedicle. Successive dilationcannulas may be subsequently inserted over the guidewire to dilate thefascia and muscle until a working cannula is large enough to accommodateanchor 12 or 14. All but the largest cannula may be removed from theworking cannula to expose a passageway through the skin to the pedicleor insertion site. In one embodiment, a hole in the pedicle may beprepared by placing a cannulated drill and/or tap over the guidewire andthrough the working cannula to prepare the pedicle for screw insertion.In other embodiments, the pedicle may be prepared with other instrumentsknown in the art, including but not limited to an awl, a trocar, and aneedle.

Any known methods of installing a pedicle screw into a prepared pediclemay be utilized. In this regard, according to one known minimallyinvasive technique, a cannulated anchor, such as screw 32 attached tosleeve 50, may be placed over the guidewire and advanced through theworking cannula to the prepared pedicle. A driving tool such as acannulated screw driver may be used to rotate screw 32 and threadedlyengage screw 32 to the bone. Sleeve 50 may follow screw 32 to the boneand the screw driver and guidewire may be removed. The working cannulamay also subsequently be removed, leaving the sleeve 50 and screw 32secured to the bone.

With the anchors 12, 14 secured to the bone and at least one sleeve 50extending from at least one anchor, stabilization member 16 may beinstalled between anchors 12, 14 utilizing insertion device 10. In thisregard, stabilization member 16 is positioned on insertion device 10 andmay be inserted into sleeve 50 with the stabilization member 16initially in a generally vertical position (as shown in FIGS. 21-22). Asinsertion device 10 is advanced in the distal direction within sleeve 50and shaft 116 is moved in the distal direction, rod 100 rotates orpivots about pivot axis 148 to a more horizontal position (as shown inFIG. 24). In this regard, insertion device 10 moves stabilization member16 in a distal direction toward anchors 12, 14. The proximal end of rod100 swings outward through opening 76 of sleeve 50 and the distal tip108 of stabilization member 100 is advanced toward the channels 26 of anadjacent anchor 14. In one exemplary embodiment, as the insertion device10 is advanced distally into sleeve 50 and shaft 116 is advanceddistally with respect to the outer guide tube 118 of insertion device10, the tip 108 of stabilization member 100 follows a generallyelliptical path entering the patient through a first opening andtraveling toward the second anchor 14 and through the channel 26 of thesecond anchor. With rod 100 in a more horizontal position, rod 100 maybe then inserted into the channel 26 of the first anchor 12 by advancingthe rod insertion tool 10 distally toward the distal end of sleeve 50.According to one variation, the clamp members 110, 112 fit withinchannel 26 of anchor 12 such that rod 100 may be loaded into the anchorat the same axial location as the clamp members 110, 112 grip or clampthe rod. Sufficient clearance, space or room is also provided within thechannel that clamp members may be radially separated apart to release ordisengage rod 100 so as to leave rod 100 installed within channel 26

The clamp members 110, 112 may be unclamped from rod 100 to allow thestabilization member 16 to be removed from the insertion device. Oncestabilization member 16 is placed within anchors 12, 14 to the desiredposition, a cap and/or set screw may be driven downward, such as throughsleeve 50, to contact stabilization member 16 and fix stabilizationmember 16 to anchors 12, 14. In this regard, a driving tool may beplaced through the central channel of sleeve 50 to tighten the capand/or set screw against the stabilization member until thestabilization member is firmly seated in coupling element 42 of at leastone of anchors 12, 14.

While the invention herein disclosed has been described with referenceto specific embodiments and applications thereof, numerous modificationsand variations can be made thereto by those skilled in the art withoutdeparting from the scope of the invention as set forth in the claims.

What is claimed is:
 1. A minimally invasive vertebral stabilizationsystem, comprising: a first anchor deliverable to a vertebral body of apatient through a first opening with an access sleeve connected thereto,the access sleeve including a central channel extending therethrough anddefining a first longitudinal axis; an elongate stabilization memberextending from a proximal end to a distal end and defining a secondlongitudinal axis, wherein the stabilization member is positionablethrough the access sleeve to engage the first anchor; and astabilization member insertion device releasably and rotatably linked tothe stabilization member, the stabilization member insertion deviceconfigured and dimensioned to be received within the central channelsuch that the insertion device and stabilization member are moveable inthe longitudinal direction along the first longitudinal axis to positionthe stabilization member adjacent the first anchor, wherein thestabilization member is releasably clampable to the insertion devicebetween first and second clamping members, wherein the first clampingmember includes a first generally cylindrical protrusion insertable intoa distal portion of the insertion device and the second clamping memberincludes a second generally cylindrical protrusion insertable into thedistal portion of the insertion device, wherein the first and secondclamping members are coupled by a pin extending through a first andsecond opening in the first and second clamping members, respectively,and wherein the system further comprising a pin assembly extendingthrough the insertion device, wherein when in a first position, a distalend of the pin assembly is spaced away from the first and secondprotrusions to allow the first and second clamping members to pivotapart, and when in a second position, the distal end of the pin assemblyis positioned between the first and second protrusions to hold thestabilization member therebetween.
 2. The system of claim 1, furthercomprising a second anchor deliverable to a vertebral body of a patientthrough a second opening with a second access sleeve connected to thesecond anchor.
 3. The system of claim 2, wherein the stabilizationmember insertion device is operable to place the stabilization memberbetween the first and second anchors.
 4. The system of claim 1, whereinthe insertion device extends from a proximal end to a distal end along athird longitudinal axis, the insertion device comprising a first memberand a second member, wherein the first member is linearly translatablewith respect to the second member along the third longitudinal axis,wherein the stabilization member is linkingly engaged to the firstmember and rotatably engaged to the second member such that, when thefirst member is translated with respect to the second member along thethird longitudinal axis the stabilization member rotates about thesecond member.
 5. The system of claim 1, wherein the first anchorcomprises a coupling element connected to the access sleeve, thecoupling element comprising a portion for receiving the stabilizationmember, wherein when the coupling element is connected to the accesssleeve the receiving portion is unobstructed.
 6. The system of claim 2,wherein each sleeve includes a pair of longitudinal openings extendingalong opposing lateral sides, the openings providing lateral access tothe central channel.
 7. The system of claim 6, wherein at least aportion of the stabilization member is extendable through thelongitudinal openings.
 8. The system of claim 2, wherein the first andsecond anchors have a predetermined orientation within the body, andwherein the stabilization member has a geometry corresponding to thepredetermined orientation of the first and second anchors.
 9. The systemof claim 2, wherein the first and second anchors comprise polyaxialscrews.
 10. The system of claim 1, wherein the stabilization membercomprises a rod.
 11. The system of claim 10, wherein the rod has acurvilinear shape.
 12. The system of claim 10, wherein the rod has atleast one indentation along its length, wherein the stabilization memberinsertion device is clampably linked to the stabilization member aboutthe indentation.
 13. The system of claim 10, wherein the proximal end ofthe rod is configured and dimensioned to interact with the stabilizationmember insertion device.
 14. The system of claim 13, wherein theproximal end is angled with respect to a longitudinal axis of therod-and wherein the proximal end defines a concave surface.
 15. Aminimally invasive vertebral stabilization system, comprising: an accesssleeve including a central channel extending therethrough, astabilization member insertion device for delivering a stabilizationmember through the access sleeve, wherein the stabilization memberinsertion device includes a first clamping member and a second clampingmember for clamping on opposite sides of the stabilization member,wherein the access sleeve is coupled to an anchor, and wherein thesystem further comprising a pin assembly extending through the insertiondevice, wherein when in a first position, a distal end of the pinassembly is spaced away from the first and second protrusions to allowthe first and second clamping members to pivot apart, and when in asecond position, the distal end of the pin assembly is positionedbetween the first and second protrusions to hold the stabilizationmember therebetween.
 16. The system of claim 1, wherein the insertiondevice comprises an outer guide tube having a pusher member extendingtherethrough, wherein the pusher member is configured to enable pivotingof the stabilization member.
 17. The system of claim 16, wherein thepusher member is operably connected to a knob such that rotation of theknob causes linear translation of the pusher member with respect to theouter guide tube.
 18. The system of claim 1, wherein the first clampingmember includes a plurality of first flange portions extending laterallyinward and the second clamping member includes a plurality of secondflange portions extending laterally inward, wherein the first and secondclamping members are assembled with the first and second flange portionsoverlapping laterally.
 19. The system of claim 10, wherein the first andsecond clamping members engage an upper portion of the rod and not theproximal or distal end of the rod.